Registration Dossier

Administrative data

Description of key information

There are 10 skin irritation and 6 eye irritation studies for the hydrotrope category substances.

The studies consistently demonstrate that the hydrotrope substances are not irritating or only slightly irritating to the skin and slightly to moderately irritating to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Please See Category Approach
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: As described in the U.S. Federal Register Vol. 38, No. 187, Section 1500:41, 1973
Deviations:
not specified
Principles of method if other than guideline:
Shaved skin; abraded and non-abraded; two sites per animal; exposed area covered; oedema and erythema assessed at 24 and 72 hours; primary irritation index evaluated following Draize scoring procedure.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS- Source: "recognized breeders"- Age at study initiation: 14-16 weeks- Weight at study initiation: 2.3 Kg average- Housing: caged singularly- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 °C +/- 2 °C- Humidity (%): 50-70%- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): natural lighting conditionsIN-LIFE DATES: From: To: no data
Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 mL- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single application; patch removed at 24 hours but no indication of excess material wiped off
Observation period:
24 and 72 hours
Number of animals:
6 females
Details on study design:
TEST SITE- Area of exposure: Two 2.5 cm sites, one abraded and one not abraded- % coverage: no data- Type of wrap if used: Smith & Nephew Elastic bandage covered entire trunk of animal- 24 hours prior to dermal application, the backs of the rabbits were shaved over an area of at least 10% of the trunk. Two test sites lateral to the mid line of the back were used on each animal. Immediately before teh application of the test substance, the right hand site was abraded witht he point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact. REMOVAL OF TEST SUBSTANCE- Washing (if done): not indicatedSCORING SYSTEM: J.H. Draize (1959) - primary irritation score (average for erythema and oedema for all six animals)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
>= 0.1
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
No irritation on intact skin. Slight erythema (score = 1) in 3 of 6 animals at 24 hours with abraded skin. No oedema observed in any animals.
Other effects:
None reported.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: primary irritation score of 0.1
Conclusions:
Sodium toluene sulfonate is a mild irritant
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Please see Category Approach
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Hazelton Research Products, Michigan- Age at study initiation: 4 months- Weight at study initiation: males 2722-2783g; females 2600-2779g- Housing: individually in hanging stainless steel wire mesh cages- Diet: up to 125 g/day - Water: ad libitum- Acclimation period: minimum of 7 daysENVIRONMENTAL CONDITIONS- Temperature (°C): controlled - Humidity (%): controlled- Air changes (per hr): controlled- Photoperiod (hrs dark / hrs light): 12/12- other: animals were maintained in accordance with the recommendations contained in the D.H.H.S. Publication "Guide for Care and Use of Laboratory Animals IN-LIFE DATES: From: April 13 To: April 18
Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of animal served as control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL- Concentration (if solution): 31.2% active ingredientVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle used
Duration of treatment / exposure:
The test substance was instilled into the cupped conjunctival sac of the right (test) eye and the eyelids were then gently held together for one second before release.
Observation period (in vivo):
72 hours total
Number of animals or in vitro replicates:
4 male and 4 female
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): not doneSCORING SYSTEM: Draize methodTOOL USED TO ASSESS SCORE: fluoresceinLeft eye of each test animal served as control. Manipulated in an identical manner as right (test) eye except no test substance administered
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
>= 0 - <= 18.6
Max. score:
18.6
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
hour 1 = 18.6; hour 24 = 6.2; hour 48 = 0.8; hour 72 = 0.0
Other effects:
The score for redness of the conjunctivae ranged from 3-2 at 1 hour but cleard by 48 hour in 3 animals and by 72 hour in all animals.The score for chemosis of the lids and /or nictitating membranes ranged from 3-2 at 1 hour but cleared by 48 hour in all animals.The score for conjuntival discharge ranged from 2-1 at 1 hour but none noted by 24 hours. Discharge was clear at 1 hour.
Interpretation of results:
other: mildly irritating
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
The test substance is mildly irritating to the eye
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Please see Category Approach
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Dr. Karl Thomae GmbH, Biberach, Germany- Age at study initiation: not mentioned- Weight at study initiation: 2.2 - 2.6 kg- Housing: conventional, singly in stainless steel cages- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany- Water (e.g. ad libitum): Drinking water ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 1- Humidity (%): 60 ± 5- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: 1989-10-10 To: 1989-10-31
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, and 6, 8, 10, 13, 17 and 21 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): with warm physiological saline- Time after start of exposure: 24 hoursSCORING SYSTEM: according to guidelineTOOL USED TO ASSESS SCORE: ophthalmic lamp, fluorescein 72 hours after administration
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
31.2
Max. score:
110
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
AVERAGE SCORE (24, 48 and 72 h)- Cornea: 2.0- Iris: 1.0- Conjunctivae (Redness): 3.0- Conjunctivae (Chemosis): 2.11
Other effects:
Dark red erythema, strong swelling and necrotic variations of mucosa and nictitating membrane, all animals. Opacity and hemorrhage on iris, up to 6 days on two animals; strong opacity and strong circumcorneal injection of iris on day 21 still on one animal.

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

1/2/2

 1/0/0

 2/3/2

 3/2/2

24 h

2/2/2

 1/1/1

 3/3/3

 2/3/2

48 h

 2/2/2

 1/1/1

 3/3/3

 2/2/2

72 h

 2/2/2

 1/1/1

 3/3/3

 2/2/2

Average 24h, 48h, 72h

 2.00

 1.00

 3.00

 2.11

Area effected

1.44

 -

 -

 -

Reversibility*)

 n.

 n.

 n.

 n.

Average time (unit) for reversion

-

 -

 -

 -

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:
moderately irritating
Remarks:
Migrated information Risk of serious damage to eyes Criteria used for interpretation of results: EU
Conclusions:
The test item had a moderately irritating effect on the eyes. 1 of 3 animals showed irreversible damages at cornea, iris and conjunctivae.
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Please See Category Approach
Reason / purpose:
read-across source
Principles of method if other than guideline:
6 animals; eyes examined with Fluorescein 72 hours before testind; test substance instilled into the conjuntival sac of one eye in each animal; washedout at 24 hours; evaluated at 1, 24, 48 and 72hours
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: no data- Age at study initiation: no data- Weight at study initiation: no data- Housing: individually housed in metal cages elevated above the droppings- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 72 hoursENVIRONMENTAL CONDITIONS- Temperature (°C): no data- Humidity (%): no data- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): no dataIN-LIFE DATES: From: To: no data
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single application, washed out after 24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): washing at 24 hoursSCORING SYSTEM: scale for scoring ocular lesions as outlined by Lehman et al (Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics Assoc, Food and Drug Officials of the US, 2nd printing, Topeka, Kansas, 1965. In accordance with Section 1500.42 Chapter 2, Title 16 Code of Federal Regulations under the Federal Hazardous Substances ActTOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 hour
Score:
>= 13
Max. score:
12
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: slight erythema at 72 hours
Irritant / corrosive response data:
Maximum mean total score at 1 hr = 13.0, at 24 hr = 12.2, at 48 hr = 5.0 and at 72 hr = 2.0
Other effects:
slight eye damage in the form of moderate erythema of the palpebral and bulbar conjunctivae, a slight chemosis of the lids, a slight acccumulation of mucoid discharge and a slight to moderate corneal opacity involving one-fourth or less of the corneal surface (4 test eyes only).
Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: term defined in Federal Hazardous Substances Act
Conclusions:
The test material was found to be an eye irritant
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
Please see Category Approach
Reason / purpose:
read-across source
Principles of method if other than guideline:
Test material instilled undiluted into the conjunctival sac of six rabbits. The eyes of some treated animals were not washed following exposure and other animals had their eyes washed after 20 seconds of exposure. Exposure was followed by 14 days of observation and the grade of occular reaction, based on the scoring scale of Lehman et al 1965 (US FDA), recorded at prescribed intervals. A maximum average score for washed and unwashed eyes was calculated.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: SLK, Per-DOT, Issac's- Age at study initiation: young adult- Weight at study initiation: no data- Housing: individually in metal cages elevated above the droppings- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): no data- Humidity (%): no data- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light):no dataIN-LIFE DATES: From:April 23, 1979 To: May 7, 1979
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 mL in one eye of each animal (the other eye was not treated and served as a control)- Concentration (if solution): undilutedVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
6 of the 9 animals were treated and their eyes were not washed. The remaining 3 animals had their eyes washed for one minute following 20 seconds of exposure.
Observation period (in vivo):
All animals (both eyes) at 1, 24, 48, 72 and 96 hours; and at 7, 10 and 14 days
Number of animals or in vitro replicates:
9 total; six with eyes not washed and 3 with eyes washed
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): 3 of 9 animals. One minute washing.- Time after start of exposure: 20 seconds - All animals were immobilized in a suitable restrainer rack for one hour following treatmentSCORING SYSTEM: scale for scoring as outlined by Lehman, A.J. et al. in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, 1965.TOOL USED TO ASSESS SCORE: fluorescein sodium 2% on the cornea
Irritation parameter:
other: maximum average score
Basis:
other: for the unwashed eyes and for the washed eyes
Time point:
other: 24 hours for unwashed; 48 hours for washed
Score:
ca. 13.7 - ca. 17.3
Max. score:
17.3
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: total possible maximum score is 110
Irritant / corrosive response data:
Rabbits with treated eyes that were not washed produced within 24 hours conjunctival lesions in the form of a moderate erythema of the palpebral and bulbar conjunctivae, a slight to moderate chemosis of the lids, a slight to moderate watery-mucoid discharge and a slight corneal opacity (4 of the 6 animals) involving one-fourth of less of the corneal surface. The test eyes showed steady improvement with the cornea of all test eyes being reaction free at 72 hours. A maximum average score of 13.7 was recorded at 24 hours.The rabbits with washed eyes following treatment produced within 24 hours conjunctival lesions in the form of a slight erythema of the palpebral and bulbar conjunctivae, a moderate chemosis of the lids, a slight watery-mucoid discharge and a slight corneal opacity involving one-fourth to one-half of the corneal surface. Little change was noted at 48 hours and some deduction of the reaction was noted at 72 hours. The corneal reaction was not present at 96 hours and all test eyes were reaction free by 10 days. A maximum average score of 17.3 was recorded at 48 hours.
Other effects:
None reported
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: maximum average score of 17.3 versus possible total maximum average score of 110
Conclusions:
Ammonium xylene sulfonate is slightly irritating to the eye
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Please see Category Approach
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Dr. Karl Thomae GmbH, Biberach, Germany- Age at study initiation: not mentioned- Weight at study initiation: 2.0 - 2.4 kg- Housing: conventional, singly in stainless steel cages- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GembH, Soest, Germany- Water (e.g. ad libitum): Drinking water ad libitum- Acclimation period: 14 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 ± 1- Humidity (%): 60 ± 5- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: 1982-08-31 To: 1982-09-20
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 50 mg
Duration of treatment / exposure:
The test substance was not washed out of the eyes of the treated animals and remained until the test was terminated.
Observation period (in vivo):
1, 24, 48 and 72 hours, and 6, 8 and 14 days after application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCETest substance was not washed outSCORING SYSTEM: according to guidelineTOOL USED TO ASSESS SCORE: ophthalmic lamp, the disappearance of corneal findings was checked by adding Sodium-Fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.44
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.94
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
see table below

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

1/1/1/1/1/1

 0/0/0/0/0/0

 1/1/1/1/1/1

 1/1/1/3/1/2

24 h

 1/1/1/1/1/1

 1/1/1/1/1/1

 2/1/1/1/2/1

 1/1/0/2/1/0

48 h

 1/1/1/1/1/1

 0/1/0/1/0/0

 1/1/1/1/1/1

 0/0/0/1/0/0

72 h

 1/1/1/1/1/1

 0/0/0/0/0/0

 0/1/0/1/1/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

 1.00

 0.44

 0.94

 0.33

Reversibility*)

 c.

 c.

 c.

 c.

Average time (unit) for reversion

 14 days

 72 hours

 6 days

 72 hours

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Animals #1 -3: male; #4 -6: female

 

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Please see Category Approach
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Kuiper RAbbitry, Gary, Indiana- Age at study initiation: 8-10 weeks- Weight at study initiation: 2.59-2.66 kg- Housing: individually in steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum):ad libitum- Acclimation period: conditioned for at least 5 days prior to study. Animals were maintained according to "Guide for the Carre and Use of Laboratory Animals", National Academy Press, 1996. ENVIRONMENTAL CONDITIONS- Temperature (°C): 16 - 22- Humidity (%): 30-70- Air changes (per hr): no data- Photoperiod (hrs dark / hrs light): "light controlled room"IN-LIFE DATES: From: August 7, 2007 To: August 14, 2007
Vehicle:
unchanged (no vehicle)
Controls:
other: unexposed eye of each animal served as its own control
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit):0.1 gram- Concentration (if solution): undiluted is 40% active ingredientVEHICLE- Amount(s) applied (volume or weight with unit): no vehicle
Duration of treatment / exposure:
single dose (no washing)
Observation period (in vivo):
at 1, 24, 48 and 72 hours and at 7 days
Number of animals or in vitro replicates:
3 (males)
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): no washingSCORING SYSTEM: DraizeTOOL USED TO ASSESS SCORE: fluorescein (2%) and ultraviolet light
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
>= 23.33
Max. score:
27
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: total maximum score possible is 110
Irritant / corrosive response data:
The maximum irritation (noted as "moderate") occurred at 24 hours, with effects observed in the cornea, iris and conjunctiva of all three animals. The scores were noticeably lower at 48 hours and again at 72 hours. No irritation was detected at 7 days.
Other effects:
Final body weights were within expected range.
Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test material would be classified as Toxicity Category III in accordance with OPPTS/OECD Guidelines. The test material is moderately irritating to the eye.
Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are a total of 10 skin irritation and 6 eye irritation studies on the hydrotrope category substances.

- All skin irritation studies show results which ranged from non-irritating to slightly irritating.

- The eye irritation studies show results which ranged from slightly to moderately irritating.

The in vivo skin/eye irritation data were obtained in studies performed before any in vitro skin irritation tests had been validated and accepted for regulatory purposes. 


Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the available skin irritation studies no classification for skin effects is warranted.

The effects observed in the six eye irritation studies vary from slightly to moderately irritating. In only one of the available studies were the effects shown not to be reversible (in one single animal after 21 days). In all other studies the effects were observed to be reversible in all animals. Therefore based on the weight of evidence of data across the category members, a classification as "Eye irritant, category 2" is justified.